Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients

Zhejiang University

Status: Not yet enrolling

Conditions: Patients Receiving Invasive Mechanical Ventilation

Treatments: Device: Intelligent emergency ventilator for transport; Device: high-performance emergency ventilator for transport

Study type: Interventional

Funder types: Other

Identifiers

NCT07198269

2022YFC2403604 (Other Grant/Funding Number)

2025-0931

Details and patient eligibility

About

Brief Summary

The goal of this clinical trial is to compare whether the novel high-performance emergency transport ventilator (TV80) differs from the intelligent transport ventilator (HAMILTON-T1) in terms of oxygenation stability when used for transporting mechanically ventilated patients. It will also collect data on the novel ventilator's performance and safety in multiple transport scenarios. The main questions it aims to answer are:

1. Does the novel high-performance emergency transport ventilator (TV80) show non-inferior oxygenation stability (measured by the difference in oxygenation index before and after transport) compared with HAMILTON-T1 in transporting mechanically ventilated patients?
2. What differences exist between the two ventilators in secondary outcomes such as transport preparation time, changes in PaCO2 and pH before and after transport, and variations in tidal volume, FiO2, heart rate, oxygen saturation, and mean arterial pressure?

We will randomly assign eligible mechanically ventilated patients requiring intra-hospital or inter-hospital transport to either TV80 or HAMILTON-T1 group at a 1:1 ratio, and compare the differences in the above outcomes between the two groups.

Participants will:

1. Be screened for eligibility based on inclusion and exclusion criteria, and their legal representatives will sign the informed consent form.
2. Be randomly assigned to use either TV80 or HAMILTON-T1 group during transport.
3. Undergo blood gas analysis 1 hour after airway intervention stabilization (before transport) and within 1 hour after transport completion to calculate the oxygenation index and changes in PaCO2 and pH.
4. Have transport preparation time recorded (from the start of transport preparation, such as suctioning and pipeline organization, to the confirmation of stable vital signs before transport).
5. Have parameters such as tidal volume, FiO2 (recorded by the ventilator) and heart rate, oxygen saturation, mean arterial pressure (monitored by a incorporated module in TV80 or portable monitor along with HAMILTON-T1) recorded during transport to calculate their variations.
6. Be monitored for adverse events during transport; if severe adverse events occur, the trial will be stopped immediately, and appropriate treatment measures will be taken.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥ 18 years and < 80 years.
• Patients receiving invasive mechanical ventilation.
• Patients requiring intra-hospital transport or inter-hospital transfer.
• Patients whose legal representatives have provided written informed consent for participation in the trial.

Exclusion criteria

• Subjects with shock or hemodynamic instability that has not been treated
• Subjects receiving high-dose vasopressor support (equivalent norepinephrine dose > 1µg/kg/min)
• Patients receiving ECMO support
• Subjects with hemoglobin < 6g/dL
• Subjects with cardiac arrest without resuscitation treatment
• Patients who are moribund or discharged due to deteriorating condition
• Patients with bullae, pneumothorax without closed thoracic drainage, especially tension pneumothorax
• Massive hemoptysis, and respiratory failure caused by massive hemoptysis or severe aspiration
• Pregnant and lactating women
• Patients with mental illness
• Subjects whose legal representatives have not provided informed consent
• Patients without access to trial ventilators during the trial, including when trial ventilators are in use or malfunctioning
• Expected transport duration exceeding 1 hour or combined transport scenarios (helicopter combined with ambulance)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Novel high-performance ventilator for transport

Experimental group

Description:

Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80

Treatment:

Device: high-performance emergency ventilator for transport

Device: Intelligent emergency ventilator for transport

Intelligent ventilator for transport

Active Comparator group

Description:

Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1

Treatment:

Device: high-performance emergency ventilator for transport

Device: Intelligent emergency ventilator for transport